Evaluation of Synchrony in the Post-operative Patient (SYNCHRONY)

This study has been completed.
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
First received: June 15, 2012
Last updated: January 21, 2015
Last verified: January 2015

Neurally adjusted ventilatory support improved synchronization in the medical patient. However no data are available in the postoperative patient.

This way the investigators designed a prospective randomized cross over trial to evaluate this issue in the abdominal post-operative patient.

Condition Intervention
Patient-ventilator Asynchronism
Device: MAQUET SERVOi ventilator with Edi Catheter
Device: MAQUET SERVOi ventilator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation of Synchrony in the Post-operative Patient (NAVA vs Pressure Support)

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Asynchrony index (AI) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    Number of asynchrony events/total respiratory rate

Secondary Outcome Measures:
  • PaO2/FiO2 ratio [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    ratio of partial pressure arterial oxygen and fraction of inspired oxygen

Enrollment: 29
Study Start Date: February 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Pressure support Device: MAQUET SERVOi ventilator
Pressure Support
Other Name: Pressure Support
Experimental: NAVA Device: MAQUET SERVOi ventilator with Edi Catheter
NAVA respiratory modality
Other Name: Neurally Adjusted Ventilatory Assist


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult > 18 yr-old
  • abdominal post-operative patient
  • able to trigger the ventilator

Exclusion Criteria:

  • infant
  • pregnancy
  • esophageal surgery
  • recent esophageal variceal bleeding
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01771341

Hospices Civils de Lyon- Centre Hospitalier Lyon Sud
Pierre Bénite, France, 69310
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Florent WALLET, MD Hospices Civils de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01771341     History of Changes
Other Study ID Numbers: 2010.646 
Study First Received: June 15, 2012
Last Updated: January 21, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
post operative

ClinicalTrials.gov processed this record on May 26, 2016